Subcutaneous access hub with multiple cannula ports

ABSTRACT

Subcutaneous access hub embodiments are discussed herein that include housing embodiments having a plurality of cannula ports and a fluid passageway network that allows fluid communication between a fluid source and the plurality of cannula access ports. Such a configuration may allow a user such as a patient or clinician to releasably secure the housing to an outside surface of the patient&#39;s skin. Multiple locations on the patient&#39;s skin may then be accessed for deployment of one or more delivery cannulas via a plurality of cannula ports for delivery of fluid and from the fluid source to multiple subcutaneous locations below the patient&#39;s skin and timely movement of cannula access in the patient&#39;s skin without the need for relocating the housing.

RELATED APPLICATIONS

The present application is a divisional of co-pending U.S. patentapplication Ser. No. 16/520,521, filed Jul. 24, 2019, by Paul M. DIPERNAet al. titled “SUBCUTANEOUS ACCESS HUB WITH MULTIPLE CANNULA PORTS”,which claims priority under 35 U.S.C. section 119(e) from U.S.Provisional Patent Application Ser. No. 62/703,346, filed on Jul. 25,2018, by Paul M. DIPERNA titled “HUB WITH MULTIPLE INJECTION PORTS FOREXTENDED INDWELLING”, each of which is incorporated by reference hereinin its entirety.

BACKGROUND

Many current clinical practices include changing out flexible cathetersand associated needles (often referred to as cannulas) that deliverfluids including therapeutic fluids such as medicaments from a fluidsource or supply, such as a pump or fluid reservoir for example, througha patient's skin to a subcutaneous location or position within thepatient's body. Such changes of the catheters and associated needles areoften carried out in intervals including, for example, intervals ofevery 3 days or so to prevent a variety of potential complications suchas infection. Such catheters typically include a hypodermic type needlesecured to a rigid hub. The hub may be adhered to the patient's skinwith an adhesive with the tip of the needle and distal opening thereofdisposed in the subcutaneous position where the therapeutic fluid willbe delivered. Although this practice is often performed by clinicalprofessionals, patients such as those with diabetes mellitus andafflictions requiring similar treatment often perform these tediousprocesses at home on their own due to the frequency with which they mustbe carried out.

Notwithstanding the tedious nature of such catheter changes, adhesivesthat are typically used for adhering hub assembly embodiments of suchcatheters to a patient's skin have been improving. Some such currentlyavailable adhesives may be rated/approved to be used for far longer thana typical needle change interval of every 3 days or so, for example.Some known adhesive embodiments used to adhere a hub assembly of anambulatory system to a patient's skin may last as long as 14 days andmore. Prior to these adhesive duration improvements, changing an accesssite was a necessity for multiple reasons, including removal of theassociated adhesive from the patient's skin, or to prevent infection atthe site, but now the concern is more focused on issues related to theinteraction between the patient's skin and the cannula or cannulasdeployed into the skin to a subcutaneous position.

What have been needed are subcutaneous access hub embodiments andmethods of using the same that are configured to access a plurality ofsubcutaneous cannula positions on a patient's body while takingadvantage of the extended duty cycles of adhesives that may be used tosecure components of such access hub embodiments to a patient's skin.

SUMMARY

Some embodiments of a subcutaneous access hub may include a housinghaving an outer surface, an inner surface, and an adhesive layer whichis secured to the inner surface of the housing. The adhesive layerincludes a contact surface that is configured to be releasably securedto an outside surface of a patient's skin. The housing may furtherinclude a plurality of delivery cannula ports which are disposed atdifferent positions on the housing. Each delivery cannula port mayinclude a bore that extends from the outer surface to the inner surfaceof the housing, and a septum which is disposed within and sealed acrossan outer portion of the bore. Each septum may further include a cavitywhich is disposed within the septum. The housing may further include asupply passageway which is disposed on the housing and which is in fluidcommunication with the cavity of the septum of each of the plurality ofdelivery cannula ports. The subcutaneous access hub embodiment may alsoinclude one or more delivery cannulas, each having a hollow tube with anouter contour configured to slide within the bore of each of theplurality of delivery cannula ports. Each delivery cannula also includesa wall portion, a proximal end, a distal end, a sharpened tip disposedon the distal end and an inner lumen extending an axial length of thehollow tube. The delivery cannula may also have a distal port which isin fluid communication with the inner lumen and may be disposed at adistal end of the inner lumen and hollow tube. An inlet port may bedisposed in fluid communication with the inner lumen and may also bedisposed at a proximal portion of the hollow tube. The delivery cannulamay also have an axial length sufficient for the distal port to extendbelow the contact surface of the adhesive layer when the inlet port isdisposed in fluid communication with the cavity of the septum of thedelivery cannula port.

Some embodiments of a method of accessing a plurality of subcutaneouspositions on a patient may include applying a contact surface of anadhesive layer of a housing of a subcutaneous access hub to an outersurface of a patient's skin so as to releasably secure the housing tothe outside surface of the patient's skin. The method may also includedeploying a first delivery cannula of the subcutaneous access hubthrough a first delivery cannula port of a plurality of delivery cannulaports of the housing until a distal port of the delivery cannula, whichis disposed at a distal end of the hollow tube, is disposed at a firstsubcutaneous position inward of the contact surface. In addition, forsuch deployment, an inlet port of the first delivery cannula, which isin fluid communication with the distal port via an inner lumen of thehollow tube, may be disposed in fluid communication with a first cavitydisposed within a first septum of the first delivery cannula port. Themethod may further include withdrawing the first delivery cannula fromthe first subcutaneous position and the first delivery cannula port ofthe housing and then deploying a second delivery cannula of thesubcutaneous access hub through a second delivery cannula port of theplurality of delivery cannula ports of the housing. The second deliverycannula may be deployed until a distal port of the second deliverycannula is disposed at a second subcutaneous position inward of thecontact surface and an inlet port of the second delivery cannula isdisposed in fluid communication with a second cavity disposed within asecond septum of the second delivery cannula port.

Some embodiments of a subcutaneous access hub may include a housinghaving an outer surface, an inner surface and an adhesive layer which isdisposed on the inner surface of the housing and which is configured tobe releasably secured to an outside surface of a patient's skin. Thehousing may further include a supply cannula port which is disposed onthe housing, which includes a bore that extends inwardly from the outersurface of the housing and which includes a septum disposed and sealedacross an outer portion of the bore defining a cavity that is disposedin the bore inward of the septum. The housing may also include a supplypassageway in fluid communication with the cavity of the supply cannulaport and a plurality of delivery cannula ports. Each of the deliverycannula ports is disposed at a different position on the housingequidistant from the supply cannula port and includes a bore thatextends from the outer surface to the inner surface of the housing. Thesubcutaneous access hub embodiment may also include one or more accesscannula sets, each access cannula set including a supply cannula and adelivery cannula. The supply cannula may have a hollow tubular structurethat includes a longitudinal axis, an inner lumen extending an axiallength thereof, a sharpened tip disposed on a distal end thereof, and aninlet port in fluid communication with the inner lumen disposed on thedistal end thereof. The delivery cannula may include a hollow tubularstructure having a longitudinal axis which is substantially parallel tothe longitudinal axis of the supply cannula, an inner lumen extending anaxial length thereof which is in fluid communication with the innerlumen of the supply cannula, a distal port at a distal end of thedelivery cannula in fluid communication with the inner lumen of thedelivery cannula and a sharpened tip disposed on the distal end thereof.In some cases, the longitudinal axis of the supply cannula may be spacedfrom the longitudinal axis of the delivery cannula by a distancesubstantially equal to a separation between the supply cannula port andeach of the delivery cannula ports.

Some embodiments of a method of accessing a plurality of subcutaneouspositions on a patient may include applying a contact surface of anadhesive layer of a housing of a subcutaneous access hub to an outersurface of a patient's skin so as to releasably secure the housing tothe outside surface of the patient's skin. Thereafter, a first deliverycannula of a first access cannula set of the subcutaneous access hub maybe deployed by passing a hollow tubular structure of the first deliverycannula through a first bore of the first delivery cannula port until adistal port of the first delivery cannula is disposed at a firstsubcutaneous position inward of the contact surface. The method alsoincludes deploying a supply cannula of the access cannula set such thata sharpened tip and inlet port of the supply cannula penetrates andadvances through a septum and bore of a supply cannula port of thehousing until an inlet port of the supply cannula is disposed in fluidcommunication with a cavity of the supply cannula port. Thereafter, thefirst delivery cannula may be withdrawn from the first subcutaneousposition and the first delivery cannula port of the housing. Thereafter,a second delivery cannula of a second access cannula set may then bedeployed by passing a hollow tubular structure of the second deliverycannula through a second bore of the second delivery cannula port untila distal port of the second delivery cannula is disposed at a secondsubcutaneous position of the patient's body inward of the contactsurface.

Certain embodiments are described further in the following description,examples, claims and drawings. Features of the embodiments will becomemore apparent from the following detailed description when taken inconjunction with the accompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of a housing embodiment of a subcutaneous accesshub embodiment that includes three delivery cannula ports.

FIG. 2 is a side view of the housing of the subcutaneous access hubembodiment of FIG.

FIG. 2A is a bottom view of the housing embodiment of FIG. 1.

FIG. 2B is an elevation view of a subcutaneous access hub embodimentintegrated with a fluid source embodiment.

FIG. 3 is a side view of the housing of the subcutaneous access hubembodiment of FIG. 1 and a fluid source coupled in fluid communicationthereto.

FIG. 4 is an elevation view in partial section of a delivery cannulaembodiment of the subcutaneous access hub embodiment.

FIG. 5 is a section view of the delivery cannula embodiment of FIG. 4taken along lines 5-5 of FIG. 4.

FIG. 5A is a transverse cross section view of the delivery cannulaembodiment of FIG. 5 taken along lines 5A-5A of FIG. 5.

FIG. 6 is an enlarged view of the inlet port of the delivery cannula ofFIG. 5 indicated by the encircled portion 6-6 of FIG. 5.

FIG. 6A is an elevation view in partial section of a delivery cannulaembodiment that includes a soft pliable hollow tubular structure and aninserter needle disposed within an inner lumen thereof.

FIGS. 7A-7C are elevation views in section that illustrate deployment ofthe subcutaneous access hub embodiment of FIGS. 1-6 on a patient's skin.

FIG. 8 is a perspective view of a housing embodiment of a subcutaneousaccess hub embodiment similar to the housing embodiment of FIG. 1coupled to a fluid source and with the housing embodiment including 5delivery cannula ports.

FIG. 9 is a perspective view of a housing embodiment of a subcutaneousaccess hub embodiment which is similar to the housing embodiment of FIG.1, which is coupled to a fluid source and which includes a rectangularconfiguration with 10 delivery cannula ports.

FIG. 10 is a top view of a housing embodiment of a subcutaneous accesshub embodiment that includes a supply cannula port and three deliverycannula ports.

FIG. 11 is a side view of a housing embodiment of FIG. 10.

FIG. 11A is a bottom view of the housing embodiment of FIG. 10.

FIG. 12 is a transverse section of the housing embodiment of FIG. 10taken along lines 12-12 of FIG. 10, with the housing shown coupled to afluid source.

FIG. 13 is a perspective view of an access cannula set embodiment foruse with the housing embodiment of FIG. 10 of the associatedsubcutaneous access hub embodiment.

FIG. 13A is an elevation view in section of the access cannula set ofFIG. 13 taken along lines 13A-13A of FIG. 13.

FIG. 13B is an elevation view in partial section of an access cannulaset embodiment including a delivery cannula embodiment that includes asoft pliable hollow tubular structure and an inserter needle disposedwithin an inner lumen thereof.

FIGS. 14A-14C are elevation views in section that illustrate thesubcutaneous access hub embodiment of FIGS. 10-13A deployed on apatient's skin.

FIG. 15 is a perspective view of a housing embodiment of a subcutaneousaccess hub embodiment similar to the housing embodiment of FIG. 10coupled to a fluid source and with the housing embodiment including 5delivery cannula ports.

FIG. 16 is a perspective view of a housing embodiment of a subcutaneousaccess hub embodiment which is similar to the housing embodiment of FIG.10, which is coupled to a fluid source and which includes a rectangularconfiguration with 10 delivery cannula ports.

FIG. 17 is an elevation view in section of a cannula conditioner that isdisposed outside of a septum of a cannula port, and that may serve as adelivery cannula conditioner, supply cannula conditioner or any othertype of cannula conditioner.

The drawings are intended to illustrate certain exemplary embodimentsand are not limiting. For clarity and ease of illustration, the drawingsmay not be made to scale and, in some instances, various aspects may beshown exaggerated or enlarged to facilitate an understanding ofparticular embodiments.

DETAILED DESCRIPTION

As discussed above, many current clinical practices include changing outflexible catheters and associated needles (often referred to ascannulas) that deliver fluid from a fluid source, such as a pump orfluid reservoir for example, through a patient's skin to a subcutaneouslocation within the patient's body. Such changes of the catheters andassociated cannulas are often carried out in intervals including every 3days or so to prevent a variety of ailments and/or complications.Examples of complications might include infection of the cannula site orcreation of scar tissue at the puncture site that may make healing ofthe patient's skin more difficult. Complications such as these maycreate issues for the patient and treating clinician so compliance withregard to this practice of catheter change out is relatively highdespite being an ongoing burden and costs related to disposal of thecannula sets.

As used herein, unless noted otherwise, the term “cannula” refers to atubular structure having an inner lumen of any desired cross sectionconfiguration through which a therapeutic fluid may be delivered.Therapeutic fluids may include any fluids that provide a benefit to apatient, including glucose solutions, saline solutions and medicamentssuch as insulin, antibiotics, pain medications etc. Regarding certaincannula embodiments, in some cases a cannula embodiment may include arigid high strength structure that resists bending that may be made froma high strength material including biocompatible metallic alloys such asstainless steel, nickel titanium alloy or the like. For some cannulaembodiments, the hollow tubular structure thereof may be made from asoft pliable material such as polyurethane, polytetrafluoroethylene(PTFE) including expanded PTFE and the like. For such embodiments, aninserter needle having a sharpened distal tip that extends from a distalport of the hollow tubular structure of the cannula may disposed withinthe inner lumen of the cannula during deployment of the cannula througha cannula port and/or a patient's tissue. Once such a cannula embodimentis deployed, the inserter needle may be proximally withdrawn from theinner lumen. In addition, as used herein, the term “subcutaneous” isbeing used in a broad sense that refers to any position below an outersurface of a patient's skin, including positions within the epidermisand dermis layers of the skin and below these layers of the skin of apatient.

Although this practice is typically performed by clinical professionals,patients such as those with diabetes mellitus and afflictions requiringsimilar treatment often struggle with this practice as well, oftenperforming these processes at home due to the frequency with which theymust be carried out. With regard to patient's suffering from diabetes,the fluid source coupled to such catheters and associated cannulas mayinclude insulin pumps such as those discussed in commonly owned U.S.Patent Publication No. 2016/0361489, Ser. No. 15/122,132, titled “FluidDelivery Pump”, filed by P. DiPerna on Aug. 26, 2016, and U.S. PatentPublication No. 2019/0009023, Ser. No. 16/028,256, titled “Medical Pumpwith Flow Control,” filed by P. DiPerna et al. on Jul. 5, 2018, each ofwhich is incorporated by reference herein in its entirety.

For typical patients who are on home therapies such as insulin therapy,changing a catheter may entail a change of a fluid reservoir of aninsulin pump as well. In ambulatory systems in particular, an associatedcatheter and fluid reservoir are often changed on the same interval.This practice often encourages/incentivizes patients to leave thecatheter in longer to allow the remaining medicament to be used or topostpone the effort and cost associated with the change. Besides thecost and effort of such catheter and cannula changes, people withchronic conditions, such as diabetes, often live on an irregularrecurring schedule (such as the 3-day schedule mentioned above forexample) for catheter/cannula changes that does not repeat on standarddays creating challenges to proper compliance.

Adhesives that are typically used for adhering housing embodiments ofsuch catheter systems to a patient's skin have been improving over thepast few years. Some such adhesives may be rated/approved to be used forfar longer than a typical change interval, for example every 3 days orso. Some known adhesive embodiments such as some manufactured bycompanies such as 3M® and Avery® for example may be used to adhere anambulatory system to a patient's skin may last as long as 14 days andmore. Prior to these improvements in the duration of adhesive efficacy,changing an access site was a necessity for multiple reasons, includingremoval of the associated adhesive from the patient's skin, but now theconcern is more focused on issues related to the interaction between thepatient's skin and the cannula or cannulas deployed into the skin.

Discussed herein are a variety of intracorporal/subcutaneous access hubembodiments that may be used as part of an ambulatory fluid deliverysystem or the like. Embodiments of such intracorporal access hubs mayinclude a housing that may remain attached to the patient's skin whileproviding a clinician or patient with multiple cannula port locationsassociated with the attached housing to choose from for deployment of adelivery cannula. In this way, the cannula may be moved to a differentposition or positions at any desired interval, such as every three daysor so, while the housing remains attached and in place relative to thepatient's body including a skin surface thereof. In some cases, acannula may be removed from the patient's skin and discarded and a newone may be deployed into the patient's skin in a secondary alternativelocation relative to the patient's skin and the housing of thesubcutaneous access hub embodiment. For such embodiments, plumbing suchas passageways within the subcutaneous access hub may allow a desiredtherapeutic fluid such as a medicament to be directed from a fluidsource, to the new secondary cannula location and into the patient'sbody.

Any of the subcutaneous access hub embodiments discussed herein mayinclude a device attached to a patient's skin, including a device suchas a patch pump, that includes a subcutaneous access hub having multiplecannula port locations. Such cannula ports may include a septum, forexample, available for a cannula to pass through and into the patient'sskin. The associated housing for such embodiments may plumbed orotherwise include a network of fluid passageways to allow every one ofthe cannula port locations to get fluid into a new and differentlocation on the patient's skin. For some such embodiments, the cannulaand hub may be configured such that the fluid only flows to the patientif there is a cannula that includes an inlet port on a side of thecannula proximal of the sharp tip, for example, that aligns with alocation of a fluid passageway and/or associated cavity of the septum orother portion of a fluid passageway when the cannula is pressed throughthe respective septum. Additionally, there may be multiple fluidpassageways to deliver a plurality of therapeutic fluids through varyingcannula configurations.

Referring to FIGS. 1-9, an exemplary subcutaneous access hub embodiment10 is shown in that may include a housing 12 and a delivery cannula 14.The housing 12, as shown in FIGS. 1-3, may include an outer surface 16,an inner surface 18 disposed opposite the outer surface 16, and anadhesive layer 20 which is secured to the inner surface 18 of thehousing 12. The adhesive layer 20 includes a contact surface 22 that isconfigured to be releasably secured to an outside surface 24 of apatient's skin as shown in the section views of FIGS. 7A-7C. In somecases, the adhesive layer 20 may include an aperture 23 as shown in FIG.2A which is aligned with the bore 28 of each of the plurality ofdelivery cannula ports 26 to permit passage of the delivery cannula 14without contacting the adhesive layer 20. In some instances, theadhesive layer may include materials such as a biocompatible acrylicwith a non-woven structure or the like manufactured by a company such as3M® or Avery®. For some embodiments, the housing 12 may have an outertransverse dimension of about 5 mm to about 20 mm, a thickness betweenthe inner surface 18 and the outer surface 16 of about 5 mm to about 15mm and may be made from or include rigid or semi-rigid materials thatmay also be biocompatible including polymers such as ABS plastic,polyvinylchloride (PVC), acrylic, nylon, polycarbonate (PC),polyethylene (PE), polyethylene terephthalate (PET), cyclic olefincopolymer (COC) as well as biocompatible alloys such as stainless steelor the like.

The housing 12 may further include a plurality of delivery cannula ports26 which are disposed at different positions on the housing 12, witheach delivery cannula port 26 including a bore 28 as shown in FIG. 3that extends from the outer surface 16 to the inner surface 18 of thehousing 12, and a septum 30 which is disposed within and sealed acrossan outer portion 32 of the bore 28 as shown in FIG. 3. Each septum 30also includes a cavity 34 which is disposed within the septum 30. Insome cases, the septum 30 of each of the plurality of delivery cannulaports 26 may include a resilient, elastomeric material such as rubber,polyurethane, polyisoprene, silicone or the like. In addition, for someembodiments, it may be useful to include a target mark 27 as shown inFIG. 1 disposed on an outer surface of the septum 30 in order for a userto more accurately deploy a delivery cannula 14 into the septum 30 andthrough the bore 28 of the delivery cannula port 26.

For some embodiments, the longitudinal axes 25 of the respective bores28 of the plurality of delivery cannula ports 26 may be disposedsubstantially parallel to each other. In some cases, the longitudinalaxis 25 of each bore 28 of each of the plurality of delivery cannulaports 26 may be disposed substantially perpendicular to the innersurface 18 of the housing 12. In some cases, the inner surface 18 of thehousing 12 may be substantially flat or planar as may be the outersurface 16, however, any suitable contour may be used for either. Inaddition, any suitable number of delivery cannula ports 26 orarrangement of delivery cannula ports 26 may be used for any of thesubcutaneous access hub embodiments 10 discussed herein. For example, insome cases, the housing may include about 2 delivery cannula ports toabout 10 delivery cannula ports, more specifically, the housing mayinclude about 3 delivery cannula ports to about 6 delivery cannulaports. FIG. 8 illustrates an embodiment of a housing 12′ that is similarto the housing 12 discussed above that includes 5 delivery cannula ports26 coupled in fluid communication to the fluid source 38 by the supplyconduit 39.

In addition, the subcutaneous access hub embodiments 10 discussed hereinmay include a layout with a linear array which could improve integrationwith some systems. Such a configuration may also enable a furtherseparation between delivery cannula ports 26 and corresponding tissuesite locations. In some cases, 2 cannula ports could be placed up to 100mm away from each other enabling a wearable patch pump device havingsuch a subcutaneous access hub embodiment 10 incorporated into it tohave separate delivery cannula ports 26 at opposite ends of such adevice. In most cases, this separation adds a negligible volume to thefluid flow path due to the small cross sectional areas of the associatedfluid passageways 36 and/or supply conduits 39 required for the fluidpath. FIG. 9 illustrates an embodiment of a housing 12″ of thesubcutaneous access hub 10, similar to the housing embodiment 12discussed above, that includes a linear type array of 10 deliverycannula ports 26 in two rows. Such a rectangular housing 12″ may have amajor outer transverse dimension of about 20 mm to about 150 mm, and aminor outer transverse dimension of about 10 mm to about 100 mm.Furthermore, any of the delivery cannula ports 26 discussed herein mayfurther include an indicator 41 as shown in FIGS. 1-3 which isconfigured to indicate whether an delivery cannula 14 has previouslypenetrated the septum 30 of the delivery cannula port 26. Such optionalindicators 41, as also shown in FIGS. 12, 14A and 17, may include a thinlayer of non-elastic material such as a metal foil.

As discussed above, any of the housing embodiments 12 discussed herein(including housing embodiment 90 discussed below) may be integrated witha fluid source 38 such as a pump including patch pumps for delivery ofinsulin or any other desirable medicament or therapeutic fluid. FIG. 2Bshows an embodiment of a housing 12 of a subcutaneous access hub 10integrated with a fluid source 38 and coupled by a supply conduit 39.The entire assembly includes an adhesive layer 20 having a contactsurface 22 disposed on an inner surface thereof. The same or similararrangement may be used for the housing embodiment 92 of thesubcutaneous access hub embodiment 90 discussed below.

The housing 12 may further include a supply passageway 36 which isdisposed on the housing 12 and which is in fluid communication with thecavity 34 of the septum 30 of each of the plurality of delivery cannulaports 26. In some cases, such as with the case of the embodiment of FIG.1, the supply passageway 36 may include a network of passageways thatare in fluid communication with each of the cavities 34 of therespective septums 30 of each of the delivery cannula ports 26. Thesupply passageway 36 may also be in fluid communication with a fluidsource 38 via a supply conduit 39 which includes an inner lumen which isdisposed in fluid communication between the supply passageway 36 and thefluid source 38.

The subcutaneous access hub embodiment 10 also includes the deliverycannula 14, as shown in FIGS. 4-6A, which has a hollow tubeconfiguration with an outer contour configured to slide within the bore28 of each of the plurality of delivery cannula ports 26. The deliverycannula 14 also has a wall portion 40, a proximal end 42, a distal end44, and a sharpened tip 46 disposed on the distal end 44. An inner lumen48 extends an axial length of the hollow tube, and a distal port 50which is in fluid communication with the inner lumen 48 is disposed at adistal end of the inner lumen 48. In some instances, a transversedimension of an outer surface 15 of the delivery cannula 14 may have aclose fit with an inner surface 29 of the bore 28 of each of theplurality of delivery cannula ports 26. Such a close fit between thedelivery cannula 14 and inner surface 29 of the bore 28 may be useful insome instances in order to accurately guide the delivery cannula 14 to adesired location on the patient's skin 24. In some instances, a similarresult might be achieved by including additional structures on each ofthe delivery cannula 14 and the housing 12 (not shown) that slidablycouple together and serve to accurately guide the delivery cannula 14 insubstantially linear motion to a desired location on the patient's skin24.

In such cases, a close fit between the delivery cannula 14 and bore 28might not be used as well as in any other suitable situation orembodiment. In some cases, a clearance between the outer surface 15 ofthe delivery cannula 14 and the inner surface 29 of the bore 28 of eachof the plurality of delivery cannula ports 26 may be about 0.5 percentto about 5 percent of the transverse dimension of the delivery cannula14, for example.

In some cases, the delivery cannula 14 also includes an inlet port 52which is in fluid communication with the inner lumen 48 of the deliverycannula 14. The inlet port 52 may be disposed at a proximal portion ofthe hollow tube of the delivery cannula 14. An optional grip 56 may bedisposed at the proximal end 42 of the hollow tube proximal of the inletport 52. The grip 56 may include a stop surface 54 disposed at a distalend 55 of the grip 56. The grip 56 may be used to manually grasp thedelivery cannula 14 and may also serve to define a positioning boundaryfor the axial position of the delivery cannula 14. As such, the inletport 52 may be disposed distally of the stop surface 54 of the grip 56of the delivery cannula 14 at a distance indicated by arrow 58 in FIG. 4which may be substantially equal to (or in certain cases, greater than)a distance indicated by arrow 60 in FIG. 3 between the outer surface 16of the housing 12 and the cavity 34 of each respective septum 30.

Such a configuration allows fluid communication between the cavity 34 ofeach septum 30 and the inlet port 52 of the delivery cannula 14 when thestop surface 54 is disposed adjacent an index surface such as the outersurface 16 of the housing for embodiments wherein distance 58 issubstantially equal to distance 60 as shown in FIG. 7B. For embodiments10 wherein the distance 58 is greater than the distance 60 (not shown),such fluid communication between the cavity 34 and the inlet port 52 maybe achieved with the stop surface 54 disposed away from the outersurface 16 of the housing. In most cases, as used herein, being disposed“adjacent to” would include relative contact between surfaces or nearcontact between surfaces or at least within a distance corresponding toa transverse dimension of the inlet port 52 of the delivery cannula 14in some cases. For some embodiments, the stop surface 54 associated withthe delivery cannula 14 and a corresponding index surface such as theouter surface 16 associated with the housing may include any suitablestructures of these respective elements so long as the respectivesurfaces provide a reference interaction that facilitates proper axialplacement of the delivery cannula with fluid communication between thecavity 34 and inlet port 52. For example, in some cases, the indexsurface may include the outer surface of the septum 30 rather than theouter surface 16 of the housing itself.

The delivery cannula 14 may also have an axial length indicated by arrow62 sufficient for the sharpened tip 46 and the distal port 50 to extendbelow the contact surface 22 of the adhesive layer 20 and below an outersurface of the patient's skin 24 when the stop surface 54 is disposedadjacent the outer surface 16 of the housing 12. As suc.h, the axiallength 62 of the delivery cannula 14 is greater than a distance betweenthe outer surface 16 of the housing 12 and contact surface 22 of theadhesive layer 20 as indicated by arrow 64 in FIG. 3. In some cases, theplurality of delivery cannula ports 26 of the housing 12 and thedelivery cannula 14 are configured such that the distal port 50 of thedelivery cannula 14 extends to a penetration depth 66 of about 1 mm toabout 8 mm from the contact surface 22 when the delivery cannula 14 isdeployed within the delivery cannula port 26 with the stop surface 54adjacent the outer surface 16 of the housing 12 as shown in FIG. 7.

Regarding delivery cannula embodiments 14 discussed herein, in somecases the delivery cannula embodiment 14 may include a rigid highstrength structure that resists bending that may be made from a highstrength material including biocompatible metallic alloys such asstainless steel, nickel titanium alloy or the like. Such an embodimentmay include the delivery cannula embodiment 14 of FIG. 4. In thatembodiment, the sharpened tip 46 may be integrally formed from the wallmaterial of the tubular structure of the delivery cannula 14. However,for some delivery cannula embodiments 14′ as shown in FIG. 6A, thehollow tubular structure of the delivery cannula 14′ may be made from asoft pliable material such as polyurethane, polytetrafluoroethylene(PTFE) including expanded PTFE or the like. For such delivery cannulaembodiments 14′, an inserter needle 57 having a sharpened distal tip 57′that extends from a distal port 50′ of the hollow tubular structure ofthe delivery cannula 14′ may disposed within an inner lumen of thedelivery cannula 14′ during deployment of the delivery cannula 14′through a delivery cannula port 26 and/or the patient's tissue 24′. Oncesuch a delivery cannula embodiment 14′ is deployed, the inserter needle57 may be proximally withdrawn from the inner lumen of the tubularstructure of the delivery cannula 14′. In order to seal a shaft of theinserter needle 57, an inserter septum 59 may be disposed at and sealedacross a proximal end of the tubular structure of the delivery cannula14′. After the inserter needle 57 has been withdrawn post deployment ofthe delivery cannula 14′, the passage formed by the inserter needle 57in the inserter septum 59 will self-close due to the resilient andelastic nature of the material of the septum which may include any ofthe materials discussed herein with regard to any septum embodiments 30,108, including rubber, polyurethane, polyisoprene, silicone or the like.Other than withdrawal of the inserter needle 57 post deployment, thedelivery cannula 14′ is used in the same manner as delivery cannulaembodiments 14.

Any of the subcutaneous access hub embodiments 10 discussed herein mayfurther include an optional lock (not shown) which is configured tomechanically secure the delivery cannula 14 in a secured positionrelative to the housing 12 when the delivery cannula 14 is in a deployedstate such as with the stop surface 54 of the grip 56 disposed adjacentthe outer surface 16 of the housing 12 or with the delivery cannula 14disposed in any other suitable axial position relative to the housing12.

Any of the delivery cannula port embodiments 26 discussed herein(including supply cannula port embodiments 104 and delivery cannula portembodiments 116 discussed below) may include a medicament or othersuitable cannula conditioning material disposed within or near thedelivery cannula ports 26 that may be configured to treat the deliverycannula with a conditioning material. Such a conditioning material mayinclude an analgesic, antiseptic, antibiotic, antimicrobial, or thelike. Such a conditioning material may be used, for example, to furtherreduce the chance of complications and potentially numb the location ofinterest on the patient's skin prior to insertion of the deliverycannula 14. In some cases, the cannula conditioning material could becontained between the septum 30 of the delivery cannula port 26 and apierceable barrier film or membrane. This may enable a user to insert anew delivery cannula 14 into a delivery cannula port 26 with little orno user preparation to the delivery cannula port 26 or delivery cannula14.

Referring to FIG. 17, a delivery cannula conditioner 70 is disposed onthe housing 12 outside of the septum 30 of each of the plurality ofdelivery cannula ports 26. The delivery cannula conditioner 70 shownincludes an outer membrane 72, a chamber 74 disposed inside of the outermembrane 72 and a conditioning material 76 disposed in the chamber 74between an inner surface of the outer membrane 72 and an outer surfaceof a septum 30 adjacent the outer membrane 72. In some instances, theconditioning material 76 may include an antibiotic, antiseptic,analgesic, alcohol wipe or the like. In addition, in some instances,each outer membrane 72 may include a target mark 27 disposed on an outersurface thereof. The target mark 27 may be useful to facilitate a user'sdeployment of a delivery cannula 14 into the outer membrane 72 of thedelivery cannula conditioner 70 and subsequently into the bore 28 of thedelivery cannula port 26 associated therewith.

Referring to FIGS. 7A-7C, some embodiments of a method of accessing aplurality of subcutaneous positions 80 on a patient may include applyingthe contact surface 22 of the adhesive layer 20 of the housing 12 of asubcutaneous access hub 10 to an outer surface 24 of a patient's skin soas to releasably secure the housing 12 to the outside surface 24 of thepatient's skin as shown in FIG. 7A. The method may also includedeploying a first delivery cannula 14 of the subcutaneous access hub 10through a first septum 30 of a first delivery cannula port 26 of aplurality of delivery cannula ports 26 of the housing 12. The firstdelivery cannula 14 may be so deployed by pushing or otherwise axiallytranslating the first delivery cannula 14 into the first deliverycannula port 26 as indicated by the inward arrow 77 shown in FIG. 7A.During deployment, the hollow tube structure of the first deliverycannula 14 is axially translated and passed through the first septum 30and a first bore 28 of the first delivery cannula port 26 until the stopsurface 54 of the grip 56 of the first delivery cannula 14 is disposedadjacent the index surface consisting of the outer surface 16 of thehousing 12.

The first delivery cannula 14 may be so deployed such that the distalport 50 of the first delivery cannula 14 which is disposed at the distalend 44 of the hollow tube structure is positioned at the firstsubcutaneous position 80 inward of the contact surface 22 as shown inFIG. 7B. The first delivery cannula 14 is also so deployed such that theinlet port 52 of the first delivery cannula 14 (which is in fluidcommunication with the distal port 50 via the inner lumen 48 of thehollow tube) is disposed in fluid communication with the first cavity 34which is disposed within the first septum 30 of the first deliverycannula port 26. In this case, the first cavity 34 is disposed in fluidcommunication with a supply passageway 36 of the housing 12.

For some embodiments, with such a state of deployment of the firstdelivery cannula 14, the distal port 50 of the delivery cannula 14 maybe disposed at a penetration depth 66 of about 1 mm to about 8 mm fromthe contact surface 22 of the adhesive layer 20 of the housing 12 at thefirst subcutaneous position 80. For some embodiments, the method mayfurther include delivering a therapeutic fluid 82 from the distal port50 of the first delivery cannula 14 to the first subcutaneous position80 prior to withdrawing the first delivery cannula 14 from the firstsubcutaneous position 80.

In some cases, delivering the therapeutic fluid 82 to the firstsubcutaneous position 80 includes passing the therapeutic fluid 82 fromthe fluid source 38, through the supply conduit 39 which is in fluidcommunication with the supply passageway 36 of the housing 12 asindicated by the arrow adjacent the supply conduit 39 in FIG. 7B. Thetherapeutic fluid is further advanced through the supply passageway 36and into the first cavity 34 of the first septum 30, into the inlet port50 of the first delivery cannula 14 and through the inner lumen 48 ofthe hollow tube of the first delivery cannula 14 as indicated by thearrow disposed within the supply passageway 36 also as shown in FIG. 7B.The therapeutic fluid is then emitted out of the distal port 50 and intothe patient's tissue 24′ at the first subcutaneous position 80. In somecases, the fluid source 38 includes an insulin pump and the therapeuticfluid 82 includes insulin or any other therapeutic fluid suitable foralleviating diabetes or similar ailments.

Priming an empty volume or cavity 34 of a septum embodiment 30 orassociated fluid supply conduits 39 and/or supply passageways 36 afterthe delivery cannula 14 is inserted may be achieved in a variety of waysif so desired. A volume of air disposed within an inner lumen 48 of adelivery cannula(s) 14 being put into the body may not be a significantconcern as a corresponding lack of therapeutic fluid the patient willreceive during this priming process. This lack of therapeutic fluid 82may be overcome with a prefilled delivery cannula 14 (and optionallyassociated supply conduits 39 and supply passageways 36) whereby theknown quantity of liquid 82 is then pushed into the body until thetherapeutic fluid 82 is at the distal port 50 of the delivery cannula 14or by pushing the air into the body to fill the delivery cannula 14 soas to prevent an inadvertent dose or reducing the next dose.

The method may further include subsequently withdrawing the firstdelivery cannula 14 from the first subcutaneous position 80 andwithdrawing the delivery cannula 14 completely from the first deliverycannula port 26 of the housing 12 after a suitable desired number oftherapeutic fluid delivery cycles or time period. In some cases, thefirst delivery cannula 14 may be withdrawn by axially translating thefirst delivery cannula 14 as indicated by outward arrow 79 in FIG. 7C. Asecond delivery cannula 14 may then be deployed to access a secondsubcutaneous position 80′ by passing the sharpened tip 46 of the seconddelivery cannula 14 of the subcutaneous access hub 10 through a secondseptum 30 of a second delivery cannula port 26′ of the plurality ofdelivery cannula ports 26 of the housing 12. The deployment sequenceembodiment of the second delivery cannula 14 may involve the same orsimilar processes and components as those used for the deployment of thefirst delivery cannula 14. As such, reference is made to the same FIGS.7A-7C for illustration of the deployment sequence of the second deliverycannula 14. The second delivery cannula 14 may then be further deployedby passing the hollow tube structure of the second delivery cannula 14through the second septum 30 and a second bore 28 of the second deliverycannula port 26′ until the stop surface 54 of the grip 56 of thedelivery cannula 14 is disposed adjacent the outer surface 16 of thehousing 12. The second delivery cannula 14 may further be so deployedsuch that the distal port 50 of the second delivery cannula 14 isdisposed at a second subcutaneous position 80′ inward of the contactsurface 22 of the adhesive layer 20 of the housing 12. In this position,the inlet port 52 of the second delivery cannula 14 is disposed in fluidcommunication with a second cavity 34 disposed within the second septum30 of the second delivery cannula port 26′. Once again, the secondcavity 34 may also be disposed in fluid communication with the supplypassageway 36 of the housing 12.

In some instances, the second delivery cannula 14 is so deployed byaxially translating the second delivery cannula 14 until the stopsurface 54 of the grip 56 is disposed adjacent the index surfaceconsisting of the outer surface 16 of the housing 12. For someembodiments, with such a state of deployment of the second deliverycannula 14, the distal port 50 of the second delivery cannula 14 may bedisposed at a penetration depth 66 of about 1 mm to about 8 mm from thecontact surface 22 of the adhesive layer 20 of the housing 12 at thesecond subcutaneous position 80′. For some embodiments, the method mayfurther include delivering the therapeutic fluid 82 from the distal port50 of the second delivery cannula 14 to the second subcutaneous position80′ prior to withdrawing the second delivery cannula 14 from the secondsubcutaneous position 80′ or at any other suitable time.

In some cases, delivering the therapeutic fluid 82 to the secondsubcutaneous position 80′ includes passing the therapeutic fluid 82 fromthe fluid source 38, through the supply conduit 39 which is in fluidcommunication with the supply passageway 36 of the housing 12. Thetherapeutic fluid is further advanced through the supply passageway 36and into the second cavity 34 of the second septum 30, into the inletport 50 of the second delivery cannula 14 and through the inner lumen 48of the hollow tube of the second delivery cannula 14. The therapeuticfluid 82 is then emitted out of the distal port 50 of the seconddelivery cannula 14 and into the patient's tissue at the secondsubcutaneous position 80′. In some cases, the fluid source 38 includesan insulin pump and the therapeutic fluid 82 includes insulin or anyother therapeutic fluid suitable for alleviating diabetes or similarailments. Although it may be possible in some cases to reuse the samedelivery cannula 14 for subsequent deployment into a second differentdelivery cannula port 26 after deployment into a first delivery cannulaport 26, most often a new unused second delivery cannula 14 will be usedfor deployment at a new secondary site. As such, the subcutaneous accesshub embodiments 10 discussed herein may include a plurality of deliverycannulas 14 including about 2 delivery cannulas 14 to about 20 deliverycannulas 14 or more.

Some subcutaneous access hub embodiments may include the use of anaccess cannula set with two cannulas, one for pressing through a firstseptum that is disposed adjacent a cavity in fluid communication with asupply passageway and a second hole in the housing whereby the secondcannula may be aligned with and pass through the second hole into theskin. The two cannulas may be secured relative to each other and influid communication with each other with a fluid channel disposedbetween and in fluid communication with respective inner lumens of thetwo cannulas. In addition, a similar result may be achieved with asingle cannula whereby the plumbing in the form of a fluid conduitconfiguration allows the fluid to enter the top of the cannula, withflexible tubing, for example, prior to entering the skin. FIGS. 10-16illustrate an embodiment of a subcutaneous access hub 90 that includestwo cannulas.

Referring to FIGS. 10-16, the subcutaneous access hub embodiment 90 mayinclude a housing 92 having an outer surface 94, an inner surface 96disposed opposite the outer surface 94 and an adhesive layer 98 which isdisposed on the inner surface 96 of the housing 92. The adhesive layer98 includes a contact surface 100 that is configured to be releasablysecured to the outside surface 24 of the patient's skin. In someinstances, the adhesive layer 98 may include materials such asbiocompatible acrylic with non-woven structure or the like. Thesubcutaneous access hub 90 further includes an access cannula set 102that is shown in a deployed state engaged with respective cannula portsof the housing 92 in FIG. 14B. The housing 92 includes a supply cannulaport 104 as shown in FIG. 12 which may be disposed on the housing 92 andwhich includes a bore 106 that extends inwardly from the outer surface94 of the housing 92. The supply cannula port 104 also includes a septum108 which is disposed and sealed across an outer portion 110 of the bore106 defining a cavity 112 which is disposed in the bore 106 inwardly ofthe septum 108.

The housing 92 may also include a supply passageway 114 in fluidcommunication with the cavity 112 of the supply cannula port 104. Insome cases, the septum 108 of the supply cannula port 104 may include aresilient, elastomeric material such as rubber, polyurethane,polyisoprene, silicone or the like In addition, for some embodiments, itmay be useful to include a target mark 27, such as the target mark 27shown in FIG. 1 and discussed above, disposed on an outer surface of theseptum 108 in order for a user to more accurately deploy a supplycannula 126 into the septum 108 and through the bore 106 of the supplycannula port 104. Furthermore, any of the supply cannula portembodiments 104 discussed herein may further include an indicator 41which is configured to indicate whether a supply cannula 126 (discussedbelow) has previously penetrated the septum 108 of the supply cannulaport 104.

The housing 92 also includes a plurality of delivery cannula ports 116which are each disposed at different positions on the housing 92 andwhich may be optionally disposed equidistant from the supply cannulaport 104. The delivery cannula ports 116 each include a bore 118 thatextends from the outer surface 94 of the housing 92 to the inner surface96 of the housing 92 with a longitudinal axis 120 that may optionally bedisposed parallel to a longitudinal axis 122 of the bore 106 of thesupply cannula port 104. The longitudinal axes 120 of the respectivebores 118 of the plurality of delivery cannula ports 116 may alsooptionally be disposed substantially parallel to each other in somecases. These longitudinal axes 120 of the bores 118 of the respectiveplurality of delivery cannula ports 116 may, in addition, be disposedsubstantially perpendicular to the inner surface 96 of the housing 92.In some cases, the housing 92 may include about 2 delivery cannula portsto about 10 delivery cannula ports, more specifically, about 3 deliverycannula ports to about 6 delivery cannula ports. FIG. 15 illustrates anembodiment of a housing 92′ that is similar to the housing 92 discussedabove but that includes 5 delivery cannula ports 116 which may becoupled in fluid communication to the fluid source 38 by the supplyconduit 39 once an access cannula set 102 has been deployed withinrespective cannula ports 104, 116.

In addition, the subcutaneous access hub embodiments 90 discussed hereinmay include a layout with a linear array which could improve integrationwith some systems. Such a configuration may also enable a furtherseparation between delivery cannula ports 116 and corresponding tissuesite locations on a patient's skin 24. In some cases, 2 delivery cannulaports 116 could be placed up to 100 mm away from each other enabling awearable patch pump device having such a subcutaneous access hubembodiment 90 incorporated into it to have separate delivery cannulaports 26 at opposite ends of such a device. This separation may add anegligible volume to the fluid flow path due to the small crosssectional areas of the associated fluid supply passageways 114 and/orsupply conduits 39 required for the fluid path.

FIG. 16 illustrates an embodiment of a housing 92″ of the subcutaneousaccess hub 90, similar to the housing embodiment 92 discussed above,that includes a linear type array of 10 delivery cannula ports 116disposed in two rows. Such a rectangular housing 92″ may have a majorouter transverse dimension of about 20 mm to about 150 mm, and a minorouter transverse dimension of about 10 mm to about 100 mm for someembodiments. Furthermore, any of the delivery cannula ports 116discussed herein may further include an indicator 41 which is configuredto indicate whether a delivery cannula 140 has previously been deployedin the delivery cannula ports 116. With regard to the cannula portconfiguration, in some cases, the adhesive layer 98 may include anaperture 99 as shown in FIG. 11A which is aligned with the bore 118 ofeach of the plurality of delivery cannula ports 116 to permit passage ofthe delivery cannula 140 without the delivery cannula 140 contacting theadhesive layer 98.

Referring to FIG. 17, a delivery cannula conditioner 70 is showndisposed on the housing 12 outside of the septum 30 of each of theplurality of delivery cannula ports 26. The delivery cannula conditioner70 shown includes an outer membrane 72, a chamber 74 disposed inside ofthe outer membrane 72 and a conditioning material 76 disposed in thechamber 74 between an inner surface of the outer membrane 72 and anouter surface of a septum 30 adjacent the outer membrane 72. In someinstances, the conditioning material 76 may include an antibiotic,antiseptic, analgesic, antimicrobial, alcohol wipe, or the like. Such acannula conditioner 70 may be used in conjunction with any of the supplycannula port embodiments 104 or delivery cannula port embodiments 116discussed herein for the purposes discussed above or for any othersuitable purpose.

The subcutaneous access hub embodiment 90 also includes one or moreaccess cannula sets 102 as shown in FIG. 13A. The access cannula setembodiment 102 includes the supply cannula 126 with a straight hollowtubular structure that includes a longitudinal axis 128, an inner lumen130 extending and axial length thereof, a sharpened tip 132 disposed ona distal end 134 thereof, and an inlet port 136 in fluid communicationwith the inner lumen 130 disposed on the distal end 134 thereof. Theaccess cannula set 102 may further include the delivery cannula 140which has a straight hollow tubular structure with a longitudinal axis142. The longitudinal axis 142 may optionally be disposed substantiallyparallel to the longitudinal axis 128 of the supply cannula 126. Thedelivery cannula 140 may also have an inner lumen 144 extending an axiallength thereof which is in fluid communication with the inner lumen 130of the supply cannula 126. The delivery cannula 140 also includes adistal port 146 and a sharpened tip 148 disposed at a distal end 150 ofthe delivery cannula 140. The distal port 146 is in fluid communicationwith the inner lumen 144 of the delivery cannula 140.

In some instances, a transverse dimension of an outer surface 141 of thedelivery cannula 140 may have a close fit with an inner surface 107 ofthe bore 106 of each of the plurality of delivery cannula ports 116. Asdiscussed above, such a close fit between the delivery cannula 140 andinner surface 107 of the bore 106 may be useful in some instances inorder to accurately guide the delivery cannula 140 to a desired locationon the patient's skin 24. In some instances, a similar result might beachieved by including additional structures (not shown) on each of thedelivery cannula 140 and the housing 92 that slidably couple togetherand serve to accurately guide the delivery cannula 140 in substantiallylinear motion to a desired location on the patient's skin 24. In suchcases, a close fit between the delivery cannula 140 and bore 106 mightnot be used as well as in any other suitable situation or embodiment. Insome cases, a clearance between the outer surface 141 of the deliverycannula 140 and the inner surface 107 of the bore 106 of each of theplurality of delivery cannula ports 116 may be about 0.5 percent toabout 5 percent of the transverse dimension of the delivery cannula 140.

For some embodiments, the longitudinal axis 128 of the supply cannula126 may be spaced from the longitudinal axis 142 of the delivery cannula140 by a distance indicated by arrow 151 in FIG. 13A that issubstantially equal to a separation between the longitudinal axis 122 ofthe supply cannula port 104 and the respective longitudinal axes 120 ofeach of the delivery cannula ports 116 as shown in FIG. 12. Such aconfiguration may be useful to facilitate deployment of the deliverycannula 140 into one of the plurality of delivery cannula ports 116simultaneously with deployment of the supply cannula 126 into the supplycannula port 104. The access cannula set 102 may also have a grip 152secured to the supply cannula 126 and the delivery cannula 140 which mayalso be useful in facilitating such simultaneous deployment of thedelivery cannula 140 and supply cannula 126. In some instances, the grip152 may include a rigid body that has a stop surface 154 at an inner end156 of the grip 152. The grip 152 may be secured to the supply cannula126 and the delivery cannula 140 such that the hollow tubular structureof the delivery cannula 140 is secured in fixed relation to the hollowtubular structure of the supply cannula 126.

In general, with the access cannula set 102 disposed in a deployed statewith the stop surface 154 of the grip 152 disposed adjacent an indexsurface, such as the outer surface 94 of the housing, the inlet port 136of the supply cannula will be in fluid communication with the cavity 112of the supply cannula port 104 and the distal port 146 of the deliverycannula 140 will be extending inward from the contact surface 100 of theadhesive layer 98 and into a desired subcutaneous location within thepatient's skin 24. However, for some embodiments, the stop surface 154associated with the access cannula set 102 and a corresponding indexsurface such as the outer surface 94 associated with the housing 92 mayinclude any suitable structures of these respective elements so long asthe respective surfaces provide a reference interaction that facilitatesproper axial placement of the distal port 146 of the delivery cannula140 and proper axial placement of the inlet port 136 of the supplycannula 126 with fluid communication between the inlet port 136 andcavity 112 when in a deployed state. For example, in some cases, theindex surface generally associated with the housing 92 may include anouter surface of the septum 108 of the supply cannula port 104 (or anyother suitable structure that is in fixed relation to the rigidstructure of the housing 92) rather than the outer surface 94 of thehousing 92 itself.

In addition, with regard to the embodiment shown in FIG. 13A, the supplycannula 126 and delivery cannula 140 of the access cannula set 102 mayoptionally both be formed together from a single continuous length ofhollow tubing 160 that may include a high strength resilient materialsuch as stainless steel, nickel titanium alloy, or the like. Inaddition, any of the subcutaneous access hub embodiments 90 discussedherein may further include an optional lock (not shown) which isconfigured to mechanically secure the access cannula set 102 in asecured position relative to the housing 92 when the access cannula set102 is in a deployed state with the stop surface 154 of the grip 152disposed adjacent the outer surface 94 of the housing 92 or with thesupply cannula 126 and delivery cannula 140 disposed in any othersuitable axial position relative to the housing 92.

In some cases, an axial length indicated by arrow 162 in FIG. 13A of thesupply cannula 126 that extends from the stop surface 154 to the inletport 136 may be sufficient for the sharpened tip 132 and the inlet port136 thereof to be disposed in fluid communication with the cavity 112 ofthe supply cannula port 104 when the stop surface 154 is disposedadjacent the outer surface 94 of the housing 92 as shown in FIG. 14B.For such an arrangement of fluid communication, the axial length 162 ofthe supply cannula 126 may configured so as to be greater than athickness of the septum 108 of the supply cannula port 104 as indicatedby arrow 109 shown in FIG. 12 but less than a depth of the cavity 112 asindicated by arrow 113 also shown in FIG. 12.

In addition, in some instances, an axial length of the delivery cannula140 indicated by arrow 164 as shown in FIG. 13A from the stop surface154 to the distal port 146 may be sufficient for the sharpened tip 148and the distal port 146 thereof to be extended below the contact surface100 of the adhesive layer 98 when the stop surface 154 is disposedadjacent the outer surface 94 of the housing 92. For some embodiments, alength of the plurality of distal ports 146 of the housing 92 indicatedby arrow 168 in FIG. 12 and the length 164 of the delivery cannula 140may be configured such that the distal port 146 of the delivery cannula140 extends to a penetration depth 166 as shown in FIG. 14B of about 1mm to about 8 mm from the contact surface 100 when the delivery cannula140 is disposed within the delivery cannula port 116 with the stopsurface 154 disposed adjacent the outer surface 94 of the housing 92.

It should be noted that the length 168 of the delivery cannula portembodiments 116 shown in FIG. 12 may, in some cases, correspond to athickness of the housing 92 between the outer surface 94 and innersurface 96 thereof. For some embodiments, the housing 92 may have anouter transverse dimension of 5 mm to 20 mm, a thickness between theinner surface 96 and the outer surface 94 of about 5 mm to about 15 mmand may be made from or include rigid or semi-rigid materials includingpolymers such as ABS plastic, PVC, acrylic, nylon, PET, PE, PC, COC andbiocompatible high strength alloys such as stainless steel, nickeltitanium alloy or the like.

Regarding supply cannula embodiments 126 and delivery cannulaembodiments 140 discussed herein, in some cases the supply cannulaembodiments 126 and delivery cannula embodiments 140 may include a rigidhigh strength structure that resists bending that may be made from ahigh strength material including biocompatible metallic alloys such asstainless steel, nickel titanium alloy or the like as shown as may beexemplified by the supply cannula embodiment 126 and delivery cannulaembodiment 140 of FIG. 13A. In those embodiments, the sharpened tips132, 148 may be integrally formed from the wall material of the tubularstructure of the supply cannula 126 and delivery cannula 140. FIG. 13Bshows a delivery cannula embodiment 140′ wherein the hollow tubularstructure of the delivery cannula 140′ may be made from a soft pliablematerial such as polyurethane, polytetrafluoroethylene (PTFE) includingexpanded PTFE or the like. For such delivery cannula embodiments 140′,the inserter needle 57 having a sharpened distal tip 57′ that extendsfrom a distal port 146′ of the hollow tubular structure of the deliverycannula 140′ may disposed within an inner lumen of the delivery cannula140′ during deployment of the delivery cannula 140′ through a deliverycannula port 116 and/or the patient's tissue 24′. Once such a deliverycannula embodiment 140′ is deployed, the inserter needle 57 may beproximally withdrawn from the inner lumen of the tubular structure ofthe delivery cannula 140′. In order to seal a shaft of the inserterneedle 57, an inserter septum 59 may be disposed at and sealed across aproximal end of the tubular structure of the delivery cannula 140′.After the inserter needle 57 has been withdrawn post deployment of thedelivery cannula 140′, the passage formed by the inserter needle 57 inthe inserter septum 59 will self-close due to the resilient and elasticnature of the material of the septum which may include any of thematerials discussed herein with regard to any septum embodiments 30,108, including rubber, polyurethane, polyisoprene, silicone or the like.

Referring to FIGS. 14A-14C, some embodiments of a method of accessing aplurality of subcutaneous positions 80 on a patient may include applyinga contact surface 100 of an adhesive layer 98 of a housing 92 of asubcutaneous access hub embodiment 90 to an outer surface 24 of apatient's skin at a desired location as shown in FIG. 14A. Applicationof the contact surface 100 may serve to releasably secure the housing 92to the outside surface 24 of the patient's skin at the desired location.Thereafter, the first delivery cannula 140 of the first access cannulaset 102 of the subcutaneous access hub 90 may be deployed such that thesharpened tip 148 and distal port 146 of the first delivery cannula 140is deployed in a first delivery cannula port 116 of a plurality ofdelivery cannula ports 116 of the housing 92. The deployment of thedelivery cannula 140 further includes passing the hollow tubularstructure of the first delivery cannula 140 through the first bore 118of the first delivery cannula port 116 until the distal port 146 of thefirst delivery cannula 140 (which is disposed at the distal end 150 ofthe hollow tubular structure) is disposed at a first subcutaneousposition 80 inward of the contact surface 100. The deployment of thefirst delivery cannula 140 may be carried out by axially translating thefirst delivery cannula 140 in an inward direction as indicated by arrow165 of FIG. 14A. In some cases, deploying the first delivery cannula 140as discussed above may include deploying the distal port 146 of thefirst delivery cannula 140 to a penetration depth 166 as shown in FIG.14B of about 1 mm to about 8 mm from the contact surface 100 of thehousing 92 at the first subcutaneous position 80.

The method may also include deploying the first supply cannula 126 ofthe first access cannula set 102 such that a sharpened tip 132 and inletport 136 of the first supply cannula 126 penetrates through the septum108 of the first supply cannula port 104 of the housing 92. Thedeployment and advancement of the first supply cannula 126 may alsoinclude advancing the first supply cannula 126 through the a bore 106 ofthe first supply cannula port 104 until the inlet port 136 of the firstsupply cannula 126 is disposed in fluid communication with the cavity112 of the first supply cannula port 104. The cavity 112 is disposed influid communication with the supply passageway 114 of the housing 92. Inaddition, for the first access cannula set embodiment 102 shown, theinlet port 136 is disposed in fluid communication with the distal port146 of the first delivery cannula 140. For embodiments of thesubcutaneous access hub 90 that include an access cannula set 102wherein the first delivery cannula 140 is secured in fixed relation tothe first supply cannula 126, the first delivery cannula 140 may bedeployed and inserted into the first delivery cannula port 116simultaneously with deployment and insertion of the first supply cannula126 into the first supply cannula port 104.

Thereafter, in some cases, a therapeutic fluid 82 may be delivered fromthe distal port 146 of the first delivery cannula 140 into the firstsubcutaneous position 80 prior to withdrawing the first delivery cannula140 from the first subcutaneous position 80. In some cases, deliveringthe therapeutic fluid 82 from the distal port 146 of the first deliverycannula 140 into the first subcutaneous position 80 may include passingthe therapeutic fluid 82 from the fluid source 38, through the supplyconduit 39 which is in fluid communication with the supply passageway114 of the housing 92 as indicated by the arrow disposed adjacent thesupply conduit 39 in FIG. 14B. The therapeutic fluid 82 is also passedthrough the supply passageway 114 and into the cavity 112 of the firstsupply cannula port 104, then into the inlet port 136 of the firstsupply cannula 126 as indicated by the arrow in the supply passageway114 in FIG. 14B. The therapeutic fluid 82 then passes through the innerlumen 130 of the hollow tubular structure of the first supply cannula126, through the inner lumen 144 of the first delivery cannula 140 andthen may be emitted out of the distal port 146 of the first deliverycannula 140 and into the patient's tissue at the first subcutaneousposition 80 at a desired delivery site within the patient. In somecases, the fluid source 38 includes an insulin pump and the therapeuticfluid 82 comprises insulin.

After delivery of the therapeutic fluid 82 over any suitable desirednumber of cycles, volume dispensed, or period of time, the firstdelivery cannula 140 may be withdrawn by axially translating the firstdelivery cannula 140 in an outward direction from the first subcutaneousposition 80 and the first delivery cannula port 116 of the housing 92 asindicated by arrow 167 in FIG. 14C. The first supply cannula 126 mayalso optionally be withdrawn from the supply cannula port 104 at thisstage. A second delivery cannula 140 of a second access cannula set 102may then be similarly deployed such that the sharpened tip 148 anddistal port 146 of the corresponding second delivery cannula 140 passesthrough a second delivery cannula port 116′ of a plurality of deliverycannula ports 116 of the housing 92. The deployment of the seconddelivery cannula 140 may further include passing the hollow tubularstructure of the second delivery cannula 140 through a second bore 118of the second delivery cannula port 116′ until the distal port 146 ofthe second delivery cannula 140 is disposed at a second subcutaneousposition 80′ of the patient's body inward of the contact surface 100. Insome cases, deploying the second delivery cannula 140 as discussed abovemay include deploying the distal port 146 of the second delivery cannula140 to a penetration depth 166 of about 1 mm to about 8 mm from thecontact surface 100 of the housing 92 at the second subcutaneousposition 80′. Although it may be possible to reuse an access cannula set102 in some cases, generally a new unused second access cannula set 102will be used to access a second subcutaneous position 80′ in a patientonce a first access cannula set 102 has been used to access a firstsubcutaneous position 80. As such, the subcutaneous access hubembodiments 90 may include a plurality of access cannula sets 102,including about 2 access cannula sets 102 to about 20 access cannulasets 102 or more.

A second supply cannula 126 of a second access cannula set 102 may alsothen be deployed into the same supply cannula port 104 or an alternatedifferent supply cannula port 104 depending on the configuration of thehousing embodiment 92. For example, the housing embodiment 92″ discussedabove would permit a second supply cannula 126 of a second accesscannula set 102 to be deployed into one of a plurality of second supplycannula ports 104 which are in different positions relative to the firstsupply cannula port 104.

Once the second access cannula set 102 has been deployed at a secondsubcutaneous position, a therapeutic fluid 82 may be delivered from thedistal port 146 of the second delivery cannula 140 into the secondsubcutaneous position 80′. In some cases, delivering the therapeuticfluid 82 from the distal port 146 of the second delivery cannula 140into the second subcutaneous position 80′ may include passing thetherapeutic fluid 82 from the fluid source 38, through the supplyconduit 39 which is in fluid communication with the supply passageway114 of the housing 92, through the supply passageway 114 and into thecavity 112 of the supply cannula port 104. The therapeutic fluid 82 maythen pass into the inlet port 136 of the supply cannula 126. Thetherapeutic fluid 82 then passes through the inner lumen 130 of thehollow tubular structure of the supply cannula 126, through the innerlumen 144 of the second delivery cannula 140 and then may be emitted outof the distal port 146 of the second delivery cannula 140 and into thepatient's tissue at the second subcutaneous position 80′ at a desireddelivery site within the patient. In some cases, the fluid source 38includes an insulin pump and the therapeutic fluid 82 comprises insulin.

Embodiments illustratively described herein suitably may be practiced inthe absence of any element(s) not specifically disclosed herein. Thus,for example, in each instance herein any of the terms “comprising,”“consisting essentially of,” and “consisting of” may be replaced witheither of the other two terms. The terms and expressions which have beenemployed are used as terms of description and not of limitation and useof such terms and expressions do not exclude any equivalents of thefeatures shown and described or portions thereof, and variousmodifications are possible. The term “a” or “an” can refer to one of ora plurality of the elements it modifies (e.g., “a reagent” can mean oneor more reagents) unless it is contextually clear either one of theelements or more than one of the elements is described. Thus, it shouldbe understood that although embodiments have been specifically disclosedby representative embodiments and optional features, modification andvariation of the concepts herein disclosed may be resorted to by thoseskilled in the art, and such modifications and variations are consideredwithin the scope of this disclosure.

With regard to the above detailed description, like reference numeralsused therein refer to like elements that may have the same or similardimensions, materials and configurations. While particular forms ofembodiments have been illustrated and described, it will be apparentthat various modifications can be made without departing from the spiritand scope of the embodiments of the invention. Accordingly, it is notintended that the invention be limited by the forgoing detaileddescription.

What is claimed is:
 1. A method of accessing a plurality of subcutaneouspositions on a patient, comprising: applying a contact surface of anadhesive layer of a housing of a subcutaneous access hub to an outersurface of a patient's skin so as to releasably secure the housing tothe outside surface of the patient's skin; deploying a first deliverycannula of the subcutaneous access hub through a first delivery cannulaport of a plurality of delivery cannula ports of the housing until adistal port of the first delivery cannula disposed at a distal end of ahollow tube of the first delivery cannula is disposed at a firstsubcutaneous position inward of the contact surface, and an inlet portof the first delivery cannula is disposed in fluid communication with afirst cavity disposed within a first septum of the first deliverycannula port; withdrawing the first delivery cannula from the firstsubcutaneous position and the first delivery cannula port of thehousing; and deploying a second delivery cannula of the subcutaneousaccess hub through a second delivery cannula port of the plurality ofdelivery cannula ports of the housing until a distal port of the seconddelivery cannula is disposed at a second subcutaneous position inward ofthe contact surface, and an inlet port of the second delivery cannula isdisposed in fluid communication with a second cavity disposed within asecond septum of the second delivery cannula port.
 2. The method ofclaim 1 further comprising delivering a therapeutic fluid from thedistal port of the first delivery cannula to the first subcutaneousposition prior to withdrawing the first delivery cannula from the firstsubcutaneous position.
 3. The method of claim 2 wherein delivering thetherapeutic fluid from the distal port of the first delivery cannula inthe first subcutaneous position comprises passing the therapeutic fluidfrom a fluid source, through a supply conduit which is in fluidcommunication with a supply passageway of the housing, through thesupply passageway and into the first cavity of the first septum, intothe inlet port of the first delivery cannula and through the inner lumenof the hollow tube of the first delivery cannula and then out of thedistal port of the first delivery cannula.
 4. The method of claim 3wherein the fluid source comprises an insulin pump and the therapeuticfluid comprises insulin.
 5. The method of claim 1 further comprisingdelivering a therapeutic fluid from the distal port of the seconddelivery cannula to the second subcutaneous position after deploying thedistal port of the second delivery cannula to the second subcutaneousposition.
 6. The method of claim 5 wherein delivering the therapeuticfluid from the distal port of the second delivery cannula in the secondsubcutaneous position comprises passing the therapeutic fluid from afluid source, through a supply conduit which is in fluid communicationwith a supply passageway of the housing, through the supply passagewayand into the second cavity of the second septum, into the inlet port ofthe second delivery cannula and through an inner lumen of a hollow tubeof the second delivery cannula and then out of the distal port of thesecond delivery cannula.
 7. The method of claim 6 wherein the fluidsource comprises an insulin pump and the therapeutic fluid comprisesinsulin.
 8. The method of claim 1 further comprising deploying the firstdelivery cannula until a stop surface of a grip of the first deliverycannula is disposed adjacent an outer surface of the housing with thedistal port of the first delivery cannula disposed at a penetrationdepth of 1 mm to 8 mm from the contact surface of the housing at thefirst subcutaneous position.
 9. The method of claim 1 further comprisingdeploying the second delivery cannula until a stop surface of a grip ofthe second delivery cannula is disposed adjacent an outer surface of thehousing with the distal port of the second delivery cannula disposed ata penetration depth of 1 mm to 8 mm from the contact surface of thehousing at the second subcutaneous position.
 10. The method of claim 1wherein the first delivery cannula comprises a hollow tube having a softpliable structure with an inserter needle disposed within an inner lumenof the hollow tube and a sharpened tip extending from the distal port ofthe hollow tube and further comprising withdrawing the inserter needlefrom the inner lumen of the first delivery cannula after the firstdelivery cannula has been deployed.